Exercise for Parkinson's Disease

Overseen By MacKenzie Dunlap, BS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Cleveland Clinic

Disqualifiers: Dementia, Neurocognitive impairment, Musculoskeletal issues, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial involves people with Parkinson's Disease doing two types of stationary bike exercises. One type is where they pedal at their own pace, and the other is where they are helped to pedal faster. The goal is to see if higher intensity exercise can improve their symptoms more effectively.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your antiparkinsonian medication and turn off your DBS (deep brain stimulation) during the trial session.

What data supports the effectiveness of the treatment Forced and voluntary exercise, Forced Exercise, High-Intensity Exercise, Motorized Exercise for Parkinson's Disease?

Research shows that forced exercise can improve motor function and central nervous system function in Parkinson's patients. Additionally, intensive exercise therapies like resistance and endurance training are safe and can enhance muscle strength, balance, and quality of life for those with Parkinson's. ^{1 2 3 4 5}

Is exercise safe for people with Parkinson's disease?

Research suggests that various forms of exercise, including forced and high-intensity exercise, are generally safe for people with Parkinson's disease and can be added to their treatment plan without worsening symptoms. ^{1 2 3 4 6}

How does the exercise treatment for Parkinson's disease differ from other treatments?

This exercise treatment for Parkinson's disease is unique because it involves 'forced exercise', where patients engage in high-intensity cycling at a set pace, which has shown to improve motor function and brain activity more effectively than voluntary exercise. Unlike traditional treatments that primarily rely on medication, this approach enhances the benefits of existing medications without adding side effects. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for adults with Parkinson's Disease (PD) who have had a Medtronic Percept PC DBS system in place for at least six months and stable settings for three. Participants must be able to stop PD medications and DBS, pass an exercise safety screening or get doctor clearance, and safely use a recumbent cycle.

Inclusion Criteria

My deep brain stimulation settings have been stable for 3 months.

I have had Medtronic Precept DBS devices for Parkinson's for over 6 months.

I can safely get on and off a stationary bike with a backrest.

Exclusion Criteria

Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent

I have a condition that makes it hard for me to ride a bike.

I have a neurological condition, not Parkinson's, affecting my movement or thinking.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Session

Participants complete a single 150-minute session of both forced exercise (FE) and voluntary exercise (VE) in the OFF antiparkinsonian and Off-DBS state

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in cognitive and motor function through various tests

3 days

Treatment Details

Interventions

• Forced and voluntary exercise (Behavioural Intervention)

Trial Overview The study tests the effects of one session each of forced (FE) and voluntary exercise (VE) on cognitive function in PD patients without their usual medication or DBS stimulation. The exercises are done during a single 150-minute session.

Participant Groups

Group I: Experimental Arm Experimental Treatment 1 Intervention

Two modes of high intensity exercise.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

A new forced exercise intervention has shown promising results in improving motor function and central nervous system function in patients with Parkinson's disease, building on previous animal studies that indicated neuroprotective effects.

Traditional exercise methods have not provided significant overall improvements in function for Parkinson's patients, highlighting the potential of this novel approach to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. Alberts, JL., Linder, SM., Penko, AL., et al.[2022]

In a study involving 10 patients with mild to moderate Parkinson's disease, forced exercise (FE) led to a significant 35% improvement in motor function as measured by the Unified Parkinson's Disease Rating Scale, while voluntary exercise (VE) showed no improvement.

FE not only enhanced motor function but also improved bimanual dexterity and maintained these benefits for 4 weeks after the exercise program ended, suggesting that FE may positively alter central motor control processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Ridgel, AL., Vitek, JL., Alberts, JL.[2022]

Resistance training (RT) and endurance training (ET) are safe and feasible exercise modalities for people with Parkinson's disease, showing significant benefits in muscle strength, functional capacity, and quality of life based on a review of 33 new randomized controlled trials.

RT demonstrated a strong positive impact on muscle strength (SMD = 0.83) and functional capacity, while ET improved cardiorespiratory fitness (SMD = 0.27) and also showed potential benefits for functional outcomes, indicating that both types of exercise can be effective adjunct therapies for managing Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. Gamborg, M., Hvid, LG., Dalgas, U., et al.[2022]

Forced exercise may serve as a safe additional therapy for improving motor function in individuals with Parkinson's Disease, complementing existing medical treatments.

While exercise enhances the effectiveness of anti-parkinsonian medications, it does not reduce their side effects, highlighting the need for alternative approaches like forced exercise to support patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of forced exercise cycling in individuals with Parkinson's disease. Miner, DG., Aron, A., DiSalvo, E.[2021]

Resistance Training (RT) is shown to significantly improve muscle strength in individuals with Parkinson's Disease, with a moderate effect size based on a meta-analysis of 15 randomized controlled trials.

All three exercise modalities—Resistance Training, Endurance Training, and Other Intensive Training Modalities—are safe and feasible, potentially benefiting balance, walking performance, and quality of life in Parkinson's Disease, with no reported deterioration in outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy--a systematic review and meta-analysis of randomized controlled trials. Uhrbrand, A., Stenager, E., Pedersen, MS., et al.[2018]

The SPARX Trial is a Phase II study involving 126 early-stage Parkinson's disease patients, designed to assess the feasibility and efficacy of high-intensity exercise as a treatment for PD symptoms, comparing it to moderate-intensity exercise and usual care.

The trial aims to determine if either exercise intensity can lead to meaningful clinical improvements in motor scores, while also ensuring participant safety and monitoring dropout rates, which will inform future large-scale studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Moore, CG., Schenkman, M., Kohrt, WM., et al.[2021]

A 16-week high-intensity tandem bicycle program significantly improved VO2max and motor function in 13 patients with Parkinson's Disease, while the control group showed a decline in these measures.

The exercise program also led to a more than 10-fold increase in plasma brain-derived neurotrophic factor (BDNF) levels, which correlated with improved motor function, suggesting a potential mechanism for the benefits of exercise in PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a High-Intensity Tandem Bicycle Exercise Program on Clinical Severity, Functional Magnetic Resonance Imaging, and Plasma Biomarkers in Parkinson's Disease. Segura, C., Eraso, M., Bonilla, J., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic effects of forced exercise cycling in individuals with Parkinson's disease. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy--a systematic review and meta-analysis of randomized controlled trials. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of a High-Intensity Tandem Bicycle Exercise Program on Clinical Severity, Functional Magnetic Resonance Imaging, and Plasma Biomarkers in Parkinson's Disease. [2020]